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U.S. Department of Health and Human Services

Medical Device Recalls
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11 to 19 of 19 Results
PMA Number: P160054
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Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Number: 106531US ... 2 06/18/2026 FEI # 2916596
Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog ... 2 06/18/2026 FEI # 2916596
Thoratec LLC
Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery, ABT Model/Catalog Number: 106128... 2 06/18/2026 FEI # 2916596
Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog ... 2 11/14/2025 FEI # 2916596
Thoratec LLC
Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 1065... 2 11/14/2025 FEI # 2916596
Thoratec LLC
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 ... 1 08/13/2025 FEI # 2916596
Thoratec LLC
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Versi... 1 08/13/2025 FEI # 2916596
Thoratec LLC
HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 107758UK, UK; L107758, EU Re... 1 04/17/2025 FEI # 2916596
Thoratec LLC
HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist Sys... 2 08/13/2024 FEI # 2916596
Thoratec LLC
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